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Trial · NCT00430248

Outcomes17

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPercentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit.Last Visit on treatment (up to 6 months)
Analysis was performed on intent-to-treat (ITT) subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥8.0 mg/dL. A subject's baseline value was used in the primary analysis if no postbaseline serum urate level was obtained.
percentage of subjectsNUMBER
SECONDARYPercentage of Renal Impairment Subjects Whose Final Visit Serum Urate Level is <6.0 mg/dlLast Visit on treatment (up to 6 months)Analysis was performed on the ITT subjects with mild-to-moderate renal impairment (estimated creatinine clearance of 30 mL/min to 89 mL/min), with a post-baseline serum urate level.percentage of subjectsNUMBER
SECONDARYPercentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 2 Visit.Month 2Analysis was performed on the ITT subjects with a serum urate value at Month 2 visit.percentage of subjectsNUMBER
SECONDARYPercentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 4 Visit.Month 4Analysis was performed on the ITT subjects with a serum urate value at Month 4 visit.percentage of subjectsNUMBER
SECONDARYPercentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 6 Visit.Month 6Analysis was performed on the ITT subjects with a serum urate value at Month 6 visit.percentage of participantsNUMBER
SECONDARYPercentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 2 Visit.Month 2Analysis was performed on the ITT subjects with a serum urate value at Month 2 visitpercentage of subjectsNUMBER
SECONDARYPercentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 4 Visit.Month 4Analysis was performed on the ITT subjects with a serum urate value at Month 4 visit.percentage of subjectsNUMBER
SECONDARYPercentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 6 Visit.Month 6Analysis was performed on the ITT subjects with a serum urate value at Month 6 visit.percentage of subjectsNUMBER
SECONDARYPercentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Final Visit.Last Visit on treatment (up to 6 months)Analysis was performed on the ITT subjects with a post-baseline serum urate value.percentage of subjectsNUMBER
SECONDARYPercentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 2 VisitMonth 2Analysis was performed on the ITT subjects with a serum urate value at Month 2 visit.percentage of subjectsNUMBER
SECONDARYPercentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 4 VisitMonth 4Analysis was performed on the ITT subjects with a serum urate value at Month 4 visit.percentage of subjectsNUMBER
SECONDARYPercentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 6 VisitMonth 6Analysis was performed on the ITT subjects with a serum urate value at Month 6 visit.percentage of subjectsNUMBER
SECONDARYPercentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Final VisitLast Visit on treatment (up to 6 months)Analysis was performed on the ITT subjects with a post-baseline serum urate value.percentage of subjectsNUMBER
SECONDARYMean Percent Change From Baseline in Serum Urate Levels at Month 2 Visit.Baseline and Month 2Analysis was performed on the ITT subjects with a serum urate value at Month 2 visit.percent change from baselineMEAN
SECONDARYMean Percent Change From Baseline in Serum Urate Levels at Month 4 VisitBaseline and Month 4Analysis was performed on the ITT subjects with a serum urate value at Month 4 visit.percent change from baselineMEAN
SECONDARYMean Percent Change From Baseline in Serum Urate Levels at Month 6 Visit.Baseline and Month 6Analysis was performed on the ITT subjects with a serum urate value at Month 6 visit.percent change from baselineMEAN
SECONDARYMean Percent Change From Baseline in Serum Urate Levels at Final Visit.Baseline and Last Visit on treatment (up to 6 months)Analysis was performed on the ITT subjects with a post-baseline serum urate value.percent change from baselineMEAN

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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